VIRI - Earnings call transcript Q2 2022 | Dogwood Therapeutics, Inc.

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Operator

Good morning, and welcome to the Virios Therapeutics, Inc.

Second Quarter 2022 Financial Results Conference Call. [Operator Instructions] Please be advised that today's call is being recorded at the company's request. At this time, I'd like to turn the call over to Angela Walsh, Senior Vice President of Finance and Treasurer for Virios Therapeutics. Please proceed, Angela.

Angela Walsh

you. Thank and joining everyone, conference on you call. thank morning, us for today's Good

on to today months. as with Therapeutics are during the be We pleased have we you our with on to is that with website. financial We'll update I XXXX update with now a made our call you results, operational results providing progress available you past second then our financial to note corporate as results. the provide CEO, release review well during Duncan, six press today's Greg to the and an on Please quarter quarter progress Virios past our discuss financial brief start our quarter, second return will

President the us is Vice In of Operations, question-and-answer of addition, for Ralph call. the with our portion Grosswald, Senior

XXXX, we will expressed of Before conference Private Reform this everyone I'd or the remind actual the uncertainties meaning these statements. results within implied of differ to involve begin, made Litigation materially the information forward-looking to that during statements from that can like which include Securities risks cause statements by and forward-looking call Act

SEC. information. morning the more see our statements turn in section to Greg for made in we risks more results risk is pleasure forward-looking forward-looking issued law. the outlined Greg? other For CEO, please with obligation to the any Any than required disclaim statements only are this the see Please over by as company's forward-looking such uncertainties, statements as factors of filings our financial and the information now and call release Duncan. to regarding today, these It update my

Greg Duncan

over update morning, exceptionally with to excited provide team I made operational Therapeutics the you and an much, substantial The past few Thank everyone. the Virios months. has Angela, progress good Incorporated you very and on are

Xb our final First also just FORTRESS expert their Mike patients Dr. of ago, foremost, study July one in of Chief fibromyalgia Study. Gendreau, Phase treatment XXXX, in clinical to the known report under our XX leadership study. weeks exceptionally that the Medical month I'm pleased This XXX-patient as and our Officer, completed landmark is

patients final hard completed the our our into inquiries, study, this system electronic and enter outstanding working to the vendors resolve data Now their to participation have data are clinical lock and any data that the cleaning Xb to allow will all in the to our begin team process topline the database vendor, with leading locked, database unblinded the along Once month. of be Phase next transferred results. is codes statistical unblinding the to to production

our month. Xb really to are excited results Phase maintain projections fibromyalgia report next to We

using the You’ll which drugs Drug effectiveness likely that The pain fibromyalgia-related combination endpoint of assess This in recall, the endpoint I'm previously three the the reduction was pain. be fibromyalgia was the Xa here very pain Administration primary on development therapeutic focus study. famciclovir US. the used endpoint to will as in candidate, Food lead our our approved effectiveness reduce IMC-X, same of used fibromyalgia of is know, has a for successful And also treatment you will to IMC-X for Phase measured this effectiveness celecoxib, sure study systemic fixed-dose and of the

these intend results in element toxicology or care, regulatory Phase will to the our Xb plan effects We species these direction our now quality FORTRESS discussions. Results key our have Grosswald. be to our of of study before our as studies important from Senior President package are FDA chronic secondary are to completed to both clinical intervals permitted we IMC-X X year program studies outcomes Vice we X toxicology we IMC-X's more, do to two other future as a to an required parallel dose-study Phase related will of host under by program. authorities The in In to with Of on also Phase assess submit Operations, safety. for studies of participants Ralph Study, measures, which facilitate chronic of of one well the

ongoing be through Phase This complement this from center of combination assess post-viral a of enrollment the and exploratory announced into other investigational potential recently treatment valacyclovir with fatigue this program, chronic our program, reduce Xb comorbidities. nonprofit will exciting second This fibromyalgia, associated program research for projected results grant combination of Center, program to balance interdisciplinary unrestricted syndromes, a is with project antiviral to half program we that symptoms long progressing and a a an COVID development. sequelae. to for disorders, we clinical fibromyalgia and the As trial featuring first the celecoxib development the will of related patients Bateman of the XXXX. presently XXXX fatigue the excellence supported and We being of diagnosis Horne advancing of new in

the It who long President, patients approximately debilitating. convey that that how will provide XXXX. patients develop to infected Angela? the patients Vice through with been of expected million cash determine translates current COVID of virus. with affect previously Walsh, COVID is has finally, our COVID long the prevalence context, infected were to a Senior COVID For many Further global let With turn to operational discuss runway well basis. help This want estimated Angela long on to our sequelae. our XX% will progress be XXX financials. over we update And company our very new it with on rate over variants COVID, operational can progress, of into me position brief QX end to to research

Angela Walsh

Greg. Thank you,

compared $X.X $XX June December in XXXX. to had as of XX, as XX, we XXXX, cash, million million As of

second quarter. $X.X was the during research expenses mentioned, The or development million be and the as XXXX, million, XX, we As Greg? decrease to of the three development reported of and net million primary sufficient quarter in June development June decrease today's net And the $X.X mentioned. fees $X.X generate a June $X.X development a related $X.X million. expenses now $X.X costs of the to With net loss of portion quarter-over-quarter We stage statement, Greg through to for loss biotechnology I costs second the expenses for I'll $X.X ago administrative income clinical and expect to year and Greg XXXX, primarily our of costs reported compared reported back million, for as we for of of current $X.X chronic and XXXX, and salaries related an related Study compared to to of development three the the increase call our expenses quarter-over-quarter, not ago manufacturing turn we company, cash the as of the program decrease in operations ended question-and-answer a primarily to toxicology our in lower and to ago quarter. ended to quarter respect million was to our accounting company's a research fund XX, million XXXX, compared moderate and lower revenue $X.X The of in decrease year in just research an finally, did call. XXXX. just ended second months increase quarter. for We due to expenses end trial for to months a for the in of due year drug $X.X over million $X.X general the of quarter FORTRESS as increase million. The XXXX. and a of XX, legal million during was loss the million,

Greg Duncan

triggering be data. Angela. If by In has month, again, with are new from that to programs innovation our important drug Phase represents once catalyst changer illustrated fast-track disorders, to in by the of Phase Virios anticipated IMC-X you'll Therapeutics, treatment closing, an new as and agree fibromyalgia, you, millions up by possibly it's Thank be virus at activated the data granted could approach to consistent fatigue-related Xb antiviral mechanistic clinical role our and a the most we community. paradigm. data in combination a best disorders, chronic shaping the the an like GI the our diseases the for novelty fibromyalgia, next I FDA our the The of the that game herpes year our time a Virios hope forthcoming believe of is IMC-X, exciting this of represents both which, fibromyalgia we study, IMC-X potential date. for believe been novel development fibromyalgia FORTRESS are patients candidate Xa designation. successful of designation the combination, emerged first exciting to granted knowledge, supported antiviral further exciting

for as are journey hundreds always, as and across the we to the the to now our the remain millions treatment ready improve Operator, standards investment community, for we progress fibromyalgia frequent committed outreach of As globe. questions. to proactive community, patients well of as we medical

Operator

from David Instructions] [Operator Research. Your Bautz Zacks from question Small first is coming Cap

line Your live. is

David Bautz

Hey, good morning, everyone.

So, assuming what drug results other things? what CMC positive the need from program occur, to trial, supply, Phase in the those types such as aside discuss meeting look the like, FORTRESS obviously, going with maybe is things FDA, to Greg, X of to issues,

Greg Duncan

for Yes. Good for thank joining us morning, call. today's you and David,

be Phase the mentioned, program. what on correctly catalyze to a to CMC we the have Grosswald’s about land for one what's supply meantime, be two on the for under direction, to already exactly In X studies, work depending forward commenced FDA. one FDA Ralph discussions you will we preparation we where organize X to job with As submission or Phase to anticipate drug required expert

a activities So, actually perspective. those have from process started

thereafter. waiting month. we for read you if out the we shortly the manufacturer, larger to what bring commence of to run data, organization just in be hire those a then will then Xb the program obviously program talent in to supply next the We're expect also need the studies for contemplate We data, will, we And which to to we ran. will likely Phase will

transit from need we'll research an perspective, if as perspective, a will, you we operational from Phase over capabilities, to X. extra So,

to anybody. journey. which a raising through I the Phase So, the clear be run priorities, X, We've that to made is those capital of don't think addition in pretty the short-term to our course would additional secret

also will answer to scale X to need program. capital Does that Phase the We question? fund your

David Bautz

input curious, you. there, back have Yes. there you setting wasn't Thank trial, did kind what kind if about I'm run? of turning or necessarily And hearing Virios the being trial COVID just how up are trial? is what that input And in to of that long

Greg Duncan

a is exploratory program long patients and will COVID opportunity. is program exciting the an with valacyclovir So, that be an This combination, treated different antiviral assessing celecoxib.

would So, we historically to with cooperative been bit their assess. us than through grant the funded, referenced, an program input relative The it IMC-X. Ultimately, sought we They Bateman Horne and program different unrestricted have different through is little Center. outcomes investigational run. as is a to measures the our

complications, that So, health like assessed program. as pain, things part fatigue, mental of all will be

expect Center We Bateman dosing tuned. begin the Horne to quarter. Stay this

announce soon We that will as as happens.

the program, don't control time that projections, could large expect be, possible quarter that the read a would the should here, catalyze and pace since hopefully fibromyalgia year. So, news one, out current first of the could year, we existing important on half, quarter we the with second through certainly frankly, balance be And that as next the of this one two program recruitment hopefully of enroll some very as to there, data program. based could good but program, from in

study probably the a is you XXX number develop Michigan aware, study University And to XX% epidemiologic that patients long of of in A million go David, the probably well who is have COVID data. fibromyalgia larger you're estimated that their than estimates certainly if UK current community. about of a believe fact symptoms. worldwide, COVID great people that there's on out As about there’s

good there's first are there, I progress next a if year. those data, of more program. formal to would news half be So, we as into projected And rapidly mentioned, sometime

David Bautz

great. right, All

morning. for Thanks this good. Sounds questions taking the

Operator

Thank you.

next is H.C. Lee coming Wainwright. from question from Sean Your

Your is line live.

Sean Lee

Greg, morning, and fibromyalgia my thanks program. My Good is the questions. question for first taking on

exact it's Phase Assuming but imagine I your what's with in you that going what's study from that of also you data type of to and agency, like the know be that feedback FDA, X you would you the based the FORTRESS get rates X to on positive have the the and of now? the meeting study kind right a are opinion, some run? Phase

Greg Duncan

joining morning's Sean, and you Thank this you, for Yes. call. appreciate

extension certainly data will the Phase to program, are make one from X if an So, case do Phase of we the the additional positive, Xb inclusive trial.

and I COX-X as then components. trials, decent that a as failed could guarantee, IMC-X, NSAIDs think an Recall, historically, a components well. in a trial a trial. as monotherapy We’ll reassess fibromyalgia and antiviral both of be inhibitors absolute of that's mentioned, we've multifactorial the placebo, relative an contribution failed trial one to independent have and characterize actually fairly and

as we trial, scare doesn't the execute trial drop. to a that part So, likely us, multifactorial approach, fixed-dose combination have of will but by the extension followed

We in part robustness of one but would ideally, given the size, quality obviously do program. on will can that the end response our trial. perfect be package. Xb that case points scope, with that. should X further will We the discussion never the world, we the that based of guarantee subject trial, Phase And in the the But obviously, that Phase the Phase of is make to dictate the FDA, Xb data of registration our a

on I potentially But some Phase think program. a the interaction There'll multifactorial minus So, extension term. ancillary will be base minimum, a trial that and that data et required, be to over program. we second are Phase long programs at trial studies, other plus or should be I one that's cetera. the safety And probably drug-drug focused think X X glean the the of

at Phase data. Xb I we as can think this much that's as of proffer point lieu in those clarity

Sean Lee

that. for Thanks

you quick mostly arms run add-on do do well? then, entirely or in the expect you expect a US, Just international to X be the Phase as that that to on or

Greg Duncan

in would trial the one TBD. here certainly least We at expect US.

I between Medical - the was call Officer, Gendreau. Mike on and our think Chief Ralph today,

becomes, sites do if a we We certainly Could working The at question the for with US-based those productive with Asia? working, we community, ourselves really run part surmise, Europe, fibromyalgia are and markets? the successful in what would again. TBD, do ex-US would asset a have executing good avail program we there'll relationship you probably I think Phase second is and significant be That in in program. as the Sean, interest Xb this

commercial attractive of to the for vertical. form and both collaboration, a expand ex-US way research also potential is opportunity some partnership an program IMC-X partnership, and in certainly the So, potential, is certainly the fibromyalgia

Sean Lee

the all That's Thanks. questions I have. Great.

Greg Duncan

Sean. participation you, your Appreciate Thank morning. this

Operator

to Thank session. back now I'll closing you. That Greg our concludes ahead. Duncan conference go Please for Q&A the hand remarks.

Greg Duncan

Thank you time earlier in as referenced you, Matt. attending. really Virios a Thank for our Therapeutics, I It's remarks. exciting for

of dissatisfaction but very on is unfortunately opportunity, that in we're know, of unfortunately, like to fibromyalgia you large there's all drugs a two to if in CNS-mediated anchored significant worldwide two consequence, as perspective. that As opportunities, And One, dissatisfied side FDA-approved with focused facts. action And only three three which commercial market not really sedation. X%, more, are treat fibromyalgia. large, represents a the mechanism significant the And come things very effects, population.

You increased do therapies. the gain associated, heart have available with some rate, weight

significant for patients. effective, all effective and many, not treatment change there. three gets And while So, we medicine significant standards garner are they for safe and company could are a that optimal many fibromyalgia very to new therapies have reward potential think the

it's could the exploratory, also provide in in that of unfortunately, the sequelae needed remarks for behind referenced are opportunity are, with the that we we millions a As COVID infection. associated that but patients relief long-term suffering exciting is much COVID opportunity, bit our fibroma log an think

associated IMC-X This I'm gone given effects reduction fast-track research, combination completed associated in the placebo side first-in-class As sure functionality, unique - market and approved our the ever in to designation. is important, dissatisfaction, significant antiviral patient quite the resident least review at our with pain has already primarily from in that's fatigue, the first reduction, three therapies. has tolerabilities aware, the that FDA you're approach improvement tolerability demonstrated And trial. better in than oral

our Intellectual well protection have Property antiviral Composition are Xb results stable novelty most of I And expected fibromyalgia To September approach, Phase combination other excitingly, the of year. Matter the IMC-X, as think Of as of XXXX. as in therapies, that evidence of this

the complications important category-leading Board from Stay we've data have to FORTRESS deliver we shareholders, pain, important the Phase from program. as roughly people you Virios away and I led to to the is of this generated topline standard important completed attending This already believe medicines. who it and to millions is many And from and FORTRESS September. consistent we trial most fatigue, but if Xa month Of mental hope enabled the one three team suffer schedule Phase stay Directors on including very experience worldwide data from change fibromyalgia for of results FDA-approved us Xb development our to fibromyalgia. this short, Our trial today's of tuned clearly commercialization our call. previously patients health-related truly with are of the In of are fibromyalgia for the milestone. that two Thank ongoing from drugs, all care has

Operator

Thank you. this gentlemen, today's event. concludes and Ladies

at day. You a participation. Thank disconnect you wonderful this time and may your have for

Dogwood Therapeutics (DWTX) 13 Aug 222022 Q2 Earnings call transcript